AstraZeneca

EMA backs datopotamab deruxtecan, but lung cancer access remains unclear

EMA · lung cancer · 9 min

EMA recommended datopotamab deruxtecan in Europe, but the supported EU approval in the evidence base is for HR-positive, HER2-negative breast cancer rather than lung cancer. In the U.S., DATROWAY has accelerated approval for EGFR-mutated NSCLC, making this a key catalyst-tracking update for BD teams and investors.

EMA backs datopotamab deruxtecan for advanced lung cancer

EMA · lung cancer · 10 min

EMA action on datopotamab deruxtecan adds a key catalyst for lung cancer tracking, even as the program’s regulatory path differs by region. For BD teams, investors, and analysts, the story now centers on approval status, label scope, and the next clinical and filing milestones.

AstraZeneca and Daiichi Sankyo datopotamab deruxtecan hits lung cancer endpoint

oncology · 8 min

AstraZeneca and Daiichi Sankyo datopotamab deruxtecan met the dual primary endpoint of progression-free survival in TROPION-Lung01, strengthening the program’s clinical case in advanced NSCLC. The readout matters for investors and BD teams because it arrives alongside an FDA-labeled EGFR-mutated NSCLC indication and a mixed breast cancer survival backdrop.

5 Notable Oncology FDA Approvals Granted in May: A B2B Analysis

FDA · oncology · 6 min

In May 2026, the FDA granted five major oncology approvals, including a first-in-class combination for non-muscle invasive bladder cancer. This analysis covers the approvals, their competitive impact, and next milestones for pharma teams.

Pharma bets on PD-1/VEGF bispecifics: Is lung cancer the wrong target?

FDA · non-small cell lung cancer · 5 min

While many drugmakers are focused on lung cancer for PD-1/VEGF bispecifics, emerging evidence shows the liver may offer higher value. This analysis covers the mechanism, key players, and strategic implications for pharma teams.

AstraZeneca's Camizestrant: Navigating Divergent Regulatory Paths for Breast Cancer Treatment

FDA · breast cancer · 6 min

AstraZeneca's breast cancer drug, camizestrant, faced a significant regulatory divergence with CHMP approval in Europe contrasting with an FDA rejection. This split highlights evolving global regulatory landscapes and presents key considerations for pharmaceutical business development and investment strategies.

ASCO26: AstraZeneca's Camizestrant Data Aims to Sway FDA Approval

FDA · 8 min

AstraZeneca is presenting new data for its oral selective oestrogen receptor degrader (SERD), camizestrant, at ASCO26, hoping to bolster its case for FDA approval. The drug demonstrated a 56% reduction in the risk of disease progression or death in recent trials.

FDA Delays Decision on AstraZeneca's Camizestrant Following Negative Adcomm Vote

FDA · breast cancer · 9 min

The FDA has extended its review period for AstraZeneca's oral SERD drug, camizestrant, following a negative recommendation from an advisory committee. The delay stems from the regulator's need to review additional data requested after the panel raised concerns about the Phase 3 SERENA-6 trial's design and the lack of survival data.

FDA Approves AstraZeneca's Imfinzi-BCG Combination for High-Risk NMIBC

FDA · NMIBC · 8 min

The FDA has approved AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This marks the first immunotherapy-based combination therapy approved for this indication.

AbbVie's Decnupaz Secures FDA Approval for Rare Blood Cancer

FDA · blastic plasmacytoid dendritic cell neoplasm · 5 min

The US FDA has approved AbbVie's antibody-drug conjugate, Decnupaz (pivekimab sunirine-pvzy), for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This marks AbbVie's first ADC entry in the blood cancer space and the first ADC approval for this ultra-rare indication.